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Director of Pharmacometrics

Reference Number: 3208
Location: NYC

Our client is a leading pharmaceutical company. They have asked us to assist them in their search for a Director of Pharmacometrics.

Major tasks and responsibilities will include:

  • Provides the expertise necessary to develop strategy and execute pharmacometrics components of clinical development programs for promising anti-tuberculosis drugs.
  • Improves and applies methods that focus on the predictiveness of preclinical and clinical assays to inform decisions related to the company’s regimen development.
  • Conceptualizes, articulates, and implements strategies for making significant and sustainable impacts on TB regimen development and decision making through the application of quantitative pharmacology and model-informed drug development.
  • Expands pharmacometrics capabilities including: population PK and PK/PD, including drug combinations, to better characterize the sources and impact of between patient variability and guides dosing decisions for clinical programs.
  • Improves and applies quantitative translation of early results to later outcomes informing decisions along the drug development lifecycle and minimizing the probability of late stage failure.  With the completion of three large Phase 3 TB clinical trials and ongoing data pooling efforts across the clinical and preclinical space there is a growing opportunity to leverage these data using pharmacometric analyses and subsequently inform development decisions.
  • Develops a population PK model capable of describing pretomanid PK and the variability in PK in healthy subjects and patients as a function of key covariates.
  • Uses published population PK models confirm that exposures (median, 5th and 95th percentiles) in Phase 2 are consistent with expectations.
  • Develops a population PK/PD model for 2-month sputum conversion.  Applies the model to assess the probable Phase 3, 2-month culture conversion based on plausible differences between Phase 2 and Phase 3.
  • Develops pediatric dosing guidelines by extrapolating the adult population PK model to a pediatric population.
  • Utilizes the model to simulate the operating characteristics of alternative trial design in a pediatric population (e.g., sample size, PK sampling strategy).
  • An End-of-Phase 2 stage gate is forthcoming for a novel combination regimen.  Pharmacometric opportunities include:Uses population PK modeling to confirm that median (and 5th/95th percentiles) exposures observed in the Phase 2 trial are consistent with prior experience.
  • Develops a population PK/PD model for culture based endpoints to better understand if any one PK parameter is a better predictor of culture conversion.
  • Uses the PK/PD model to predict Phase 3adjusting for  expected differences between Phase 2 and Phase 3 designs/population (e.g., food, age).
  • Combines findings from ongoing program with historic results to put results in perspective and quantify the probability of superiority relative to standard of care.
  • Applies drug and disease models (to be developed) from pooled data to quantitatively assess the operating characteristics of novel trial designs.
  • Develop PK/PD models to explore potential relationships between drug/regimen exposure and key safety parameters of interest.
  • Preclinical to Clinical Translation of Projects: Pools chronic mouse relapse data and calibrate to relapse. Applies to preclinical programs and stage-gate reviews.
  • Develops quantitative tools linking in vitro systems (e.g., hollow fiber) to address the precision and bias for predicting early and late clinical endpoints.  Applies to preclinical programs and stage-gate reviews.
  • Interspecies allometric scaling to predict target human dose/exposure from animals.
  • PK simulations of typical PK profiles to support human dosing and of multi parameter systems in which multiple metabolites may contribute to efficacy and toxicity.
  • Preclinical Dose fractionation PK/PD support to establish the PK driver of PD effect on Mtb and NCA analysis and reporting.

We seek candidates with the following qualifications:

  • PharmD, PhD or MD; PhD in PK/PD, clinical pharmacology, or other relevant quantitative discipline is preferred.
  • A minimum of ten years of direct industry experience in clinical pharmacometrics and experience using external resources is ideal.
  • Experience in multiple therapeutic areas and stages of development.
  • The ability to participate in scientific partnerships with other academic and industry partners is preferred.
  • Experience with all major areas of pharmacometrics, including deriving basic PK parameters, PK/PD modeling, allometric scaling, population PK and trial simulations, either through direct work in these areas or from closely overseeing others in these areas.
  • This person has a working knowledge of a range of modeling software.
  • Demonstrated ability to develop, monitor and manage budgets.
  • Uses good judgment and demonstrates a sense of appropriateness and demonstrates a high level of integrity as well as considers the consequences of personal actions and decisions. Reflects upon and learns from experience.
  • This person must have the desire to travel internationally.
  • The candidate must have a results-oriented work ethic and a positive can-do attitude. 
  • The successful candidate will be an effective leader, people manager and team builder.

 

Do you have the skills and experience we seek and want to advance your career with one of the world’s leading companies? If so, please email your resume as a Word attachment to us, reference 3208. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.